epithelial ovarian carcinoma MedDRA version: 16.0 Level: PT Classification code 10061328 Term: Ovarian epithelial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
SOTIO a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female aged =18 years Patients with histologically confirmed, FIGO (Féderation Internationale de Gynécologie et d’Obstétrique) stage III epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (serous, endometrioid or mucinous), who have undergone initial or interval debulking surgery but have not reached complete remission of more than 6 months after first line Platinum (Pt) based chemotherapy, for one of the following reasons: Patients are Pt-refractory (no response) Complete remission was not reached (partial responders) Relapse within =6 months of remission (Pt-resistant) Pt-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Pt-resistant) or by finding described as ‘did not reach complete clinical remission’ (Pt-refractory or Pt-partial response) Patients must have at least one measureable target lesion as defined by the RECIST 1.1 criteria Laboratory criteria (results must be obtained 4,000/mm3 (4.0 x109/L) Neutrophil count >1,500/mm3 (1.5 x109/L) Hemoglobin of at least 10g/dL (100g/L) Platelet count of at least 100,000/mm3 (100 x109/L) Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert´s syndrome are permitted) Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: FIGO I,II,IV epithelial ovarian cancer FIGO III clear cells epithelial ovarian cancer Non-epithelial ovarian cancer Borderline tumors (tumors of low malignant potential) Prior or current systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor [VEGF] therapy or hormonal therapy) except first line Pt-based chemotherapy (with or without bevacizumab) Previous radiotherapy to the abdomen and pelvis Malignancy other than epithelial ovarian cancer, except those that have been in CR for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas Patient co-morbidities: Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (HTLV) positive Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis Evidence of active bacterial, viral or fungal infection requiring systemic treatment Clinically significant cardiovascular disease including: Symptomatic congestive heart failure Unstable angina pectoris serious cardiac arrhythmia requiring medication Uncontrolled hypertension Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) <40% or serious cardiac conduction system disorders, if a pacemaker is not present Pleural and pericardial effusion of any National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) grade Peripheral neuropathy having a CTCAE =Grade 2 Active autoimmune disease requiring treatment History of severe forms of primary immune deficiencies History or anaphylaxis or other serious reaction following vaccination Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator’s opinion, would prevent participation in the trial Known hypersensitivity to any constituent in the DCVAC/OvCa Systemic immunosuppressive therapy for any reason Refusal to sign the informed consent Participation in a clinical trial using experimental therapy within the last 4 weeks before study entry; patients previously enrolled in protocol SOV01 who did not receive treatment with DCVAC/OvCa can be included in this study Fertile woman of childbearing potential not willing to use adequate contraception for the study duration and at least six months afterwards Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of adding DCVAC/OvCa to Standard of Care chemotherapy on OS in women with ovarian cancer who experienced relapse =6 months after achieving complete remission following standard first line (Pt-based) chemotherapy or did not reach complete remission;Secondary Objective: Progression free survival (PFS) Objective response rate (ORR) = complete response(CR) + partial response (PR) Biological progression free interval Immunological response Safety Changes in quality of life (QoL);Primary end point(s): OS (overall survival) defined as the time from randomization until death due to any cause;Timepoint(s) of evaluation of this end point: Time from randomization until death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS measured by modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria version 1.1. PFS is defined as the time from randomization to tumor progression or death from any cause. ORR = CR + PR measured by the RECIST 1.1 criteria Biological progression free interval defined by increasing CA 125 levels (PFIBIO) (Gynecologic Cancer Intergroup [GCIG]: http://www.gcig.igcs.org/CA125/respdef_nov2005.pdf) Immunological response – detection of entire anti-tumor response (samples to be collected and frozen);Timepoint(s) of evaluation of this end point: PFS will be measured at the End of Study and the median PFS will be presented if at least 50% of patients progress. | — |
Countries
Czech Republic, Germany, Poland
Contacts
Public ContactClinical Trial Sotio
SOTIO a.s.
Outcome results
None listed